MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced air in the patient line of a homechoice cassette without an alarm.This occurred during initial drain of peritoneal dialysis therapy.The patient was connected at the time of the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5366850
• MDR Text Key: 36216225
• Report Number: 1416980-2016-01054
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/24/2015
• Initial Date FDA Received: 01/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1